TearSolutions, Inc. has received US Food and Drug Administration (FDA) Orphan Drug (ODD) and Fast Track designations for Lacripep in neurotrophic keratitis (NK) and is initiating a phase 2 clinical trial with first patients dosed, the company said in a press release. 

The FDA's ODD provides incentives, including tax credits for clinical testing and up to 7 years of US market exclusivity upon regulatory approval. The Fast Track designation facilitates more frequent interactions with the FDA and enables a rolling review of the new drug application, expediting the development and review process for drugs that treat serious conditions.

NK is a rare, degenerative corneal disease characterized by a reduction or absence of corneal sensitivity and severe impairment of corneal healing, which can lead to persistent epithelial defects and vision loss. 

The phase 2 clinical trial is a multicenter, randomized, vehicle-controlled study to evaluate the safety and efficacy of Lacripep—a novel, first-in-class synthetic peptide derived from the human tear protein lacritin—in subjects with NK. Approximately 54 subjects will be enrolled, the company said.